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INSTITUTIONAL REVIEW BOARD

APPLICATION FOR REVIEW OF PROJECTS INVOLVING Recombinant Deoxyribonucleic acid

OR

RECOMBINANT DNA

FOR INTERNAL USE ONLY TU IRB APPLICATION NUMBER:_________________

Application Type: ___NEW ___ RESUBMISSION Date Application Submitted to IRB: ____/___/_____

___FOR ACADEMIC TEACHING PURPOSES ONLY (FACULTY ONLY)

Title of Project: _____ ____________________________________________________________________

Name of Principal Investigator: _________________________________________________

Department:

Address:

Phone:

Fax:

Email:

Co-Investigator(s): List the full name(s), title(s) and department(s) of all Co-Investigator(s) – Cite both your and their experience with this kind of research – include your name within the co-investigator(s) group to distinguish your experience among the group as the principal investigator. (If no one but you will be collecting data, state that fact.)

Faculty Sponsor: _________________________________________________

Department:

Phone:

Email:

IRB Submission: Have you submitted this study to any other IRB? No____ Yes____

A. What IRB(s)? List name of Institution(s) __________________________________ _

B. What category of review was the project submitted as? ____________________________________

C. Status of review (i.e. approved, not approved, pending). If the project was approved, please attach a

copy of the approval letter.

Joint Institutional Research: Describe how permission has been obtained from cooperating institution(s) – i.e., school, hospital, prison, or other relevant organization. (Attach letters of permission and approval.)

Does this cooperative research require additional IRB permission from another institution?

______YES ______NO

Estimated date to begin data collection: (pending IRB approval) ___________________________

Duration of project: (Please remember you may not begin data collection without IRB approval)

Start Date:_____ ____ ____ ____ Ending Date: ____________

Sponsorship:

____Project does not require funding from an outside source or a commercial sponsor

____Project requires funding from an outside source or a commercial sponsor

a. Commercial sponsor clinical contact name___________________________

b. Commercial sponsor clinical contact telephone number__________________

c. Funding source:______________________________________________

____Funding obtained

____Funding application pending

____Funding application to be submitted, deadline___________________

Please explain the scientific merit of the study in the space provided:

General Outline of Proposed Study

A. Describe the research design – include objectives, procedures (include number of times observations, examinations, tests, etc. will be conducted) and expected results. Specifically include the following:

1. Host strain(s) used, (include genus, species, and parent strains);

2. Source of DNA/RNA sequences (include genus, species, gene name and abbreviations, function of the gene);

3. Recombinant plasmid(s)/vectors used;

4. If there will be any attempts to obtain expression of foreign gene(s) - identify the gene(s) and gene(s) functions; and

5. Explain containment and safety precautions to be utilized in the proposed work and indicate where work will be conducted (i.e., Biological Safety Cabinet, other facilities); how material will be disposed of and what precautions will be taken by those handling materials. If relevant, list specific type of biological safety cabinets that will be used.

B. Aims and objectives- In lay or non-technical terms (language understood by a non-scientific member of the community), provide a 1-2 paragraph overview of the aims and objectives of this study. Avoid scientific jargon and define all abbreviations. Include a justification for how this study promotes animal or human health or advances scientific knowledge.

C. If you know that this research is exempt from review according to the NIH Guidelines for Recombinant DNA Research indicate the reason(s) why in the space provided. Please make sure to cite the regulation that constitutes the exemption within NIH Guidelines and paraphrase the regulation within your explanation.

D. Will there be a petition to NIH for exemption from the guidelines?

______YES ______NO

National Institutes of Health (NIH) Categories:

E. Please select the National Institutes of Health (NIH) category that accurately describes your experiment, where applicable.

NIH CLASS III-A:

Experiments that require Institutional Review Board (IRB) approval before the initiation of the experiment.

___ III-A-1: Deliberate transfer of a drug resistance trait to microorganisms that are known to

acquire it naturally, if such acquisition could compromise the use of the drug to control disease

agents in human or veterinary medicine or agriculture.

___ III-A-2: Certain experiments involving the deliberate transfer of recombinant DNA or DNA or RNA

derived from recombinant DNA into one or more human subjects.

NIH CLASS III-B:

Experiments that require NIH and IRB approval before the initiation of the experiment.

___III-B-1: Deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin

molecules lethal at an LD50 of less than 100 monograms per kilogram body weight (i.e.,

microbial toxins such as tetanus toxin).

___III-B-2: Accelerated Review of Human Gene Transfer Experiments.

___III-B-3: Minor Modifications to Human Gene Transfer Experiments.

CLASS III-C:

Experiments that require IRB approval before the initiation of the experiment.

___ III-C-1: Experiments using human or animal pathogens (Class 2, Class 3, Class 4, or Class 5

Agents) as host vector systems.

___ III-C-1a: Experiments involving the introduction of recombinant DNA into Class 2 agents carried

out at bio-safety Level 2 containment.

___ III-C-1b: Experiments involving the introduction of recombinant DNA into Class 3 agents carried

out at bio-safety Level 3 containment.

___ III-C-2: Experiments in which DNA from human or animal pathogens (Class 2, Class 3, Class 4, or

Class 5 Agents) is cloned in nonpathogenic prokaryotic or lower eukaryotic host-vector systems.

___III-C-2a: Experiments in which DNA from Class 2 or Class 3 Agents is transferred into

nonpathogenic prokaryotes or lower eukaryotes carried out at bio-safety Level 2 containment.

___ III-C-3: Experiments involving the use of infectious animal or plant DNA or RNA viruses in the

presence helper virus in tissue culture systems.

___ III-C-3a: Experiments involving the use of infections Class 2 animal viruses in the presence of

helper virus performed at bio-safety Level 2 containment.

___ III-C-3b: Experiments involving the use of infectious Class 3 animal viruses or defective Class 3

animal viruses in the presence of helper virus carried out at the bio-safety level containment.

___ III-C-3c: Experiments involving the use of infectious animal or plant viruses or defective animal or

plant viruses in the presence of helper virus not covered by the above sections carried out at the

bio-safety Level I containment.

F. Where will the project be carried out? (i.e., Laboratory; Greenhouse or Animal Facility.)

G. Are recombinant materials prepared or reconstituted at a location other than the administration site? ______NO ______YES (If YES, address precautions regarding transportation of the materials between the locations in the space provided.)

H. Is the goal of this research study to induce or enhance immune response in the study subjects?

______NO ______YES (If Yes, please describe the expected response.)

I. Does this research project utilize recombinant DNA methodology (i.e., Use of plasmids; retroviral vectors or other genetic constructs with Foreign DNA; Cell lines containing Foreign DNA; etc.)? (Note: Answer yes even if the materials are obtained commercially or from a collaborator.)

______NO ______YES

J. Will this project require large-scale fermentation (greater than (>) 10 liters) of organisms containing recombinant DNA molecules? Large scale (> 10 liters) requires special approval from the IRB.

______YES ______NO

K. Please provide a complete inventory of ALL Bio-safety Level 2 (BL2) agents currently located in the laboratory, or to be constructed in the proposed project.

NOTE: Include Vector name and type. If the source of the vector is a research group from another institution, provide the principal researcher’s name and hosting institution. Describe the nature of inserted sequences (i.e., structural gene, etc.). Indicate the storage area and building where these items will be stored (i.e., liquid nitrogen tank, Room 200, Building F (Forbes).

Table I-101: Bio-safety Level 2 (BL2) Agents

|VECTOR |SOURCE OR SUPPLIER NAME |EXPRESSED |

| | | |

| | | |

| | | |

| | | |

| | | |

| | | |

L. In the space provided below, describe the procedures for responding to an accidental spill(s) and/or release(s).

M. Date of most recent Laboratory Safety Inspection: _ / /____

Please attach a copy of the most recent Lab Safety Certificate.

Cell Culture Experiments:

N. In the following table (Table T-101), list the primary cell line or culture to be infected. Include species and tissue of origin, name of cell line, and recombinant DNA source to be utilized. Indicate the source or supplier of the cells (i.e., commercial supplier, distribution from another institution’s research group, etc). If the source of the vector is another institution’s research group, provide the principal researcher’s name and hosting institution.

Table T-101: Cell Lines or Cultures

|Cells to be used (Primary |Cell Type |recombinant DNA |Source or Supplier |

|culture or Cell line) | |Vector and Expressed gene | |

| | | | |

| | | | |

| | | | |

| | | | |

O. Will any recombinant DNA materials be administered to human subjects? (If YES, please describe the number of human subjects proposed to use in the research, the recombinant DNA vector and expressed gene, and the amount and titer in the space provided.

P. Will this project use viral vectors? ______ NO ______ YES (If YES, please answer the following questions.)

1. Are the viral vectors replication competent? ______YES (Proceed to Question 2) ______NO (Proceed to Question 3)

2. What is the known host range of the virus?

3. What specific method will be used to determine non-replication of viruses?

Q. Will this project use constructs which include whole viral genomes? ______ NO ______ YES (If YES, please answer the following questions.)

1. Are the constructs replication competent? ______YES (Proceed to Question 2) ______NO (Proceed to Question 3)

2. What is the known host range of the virus?

3. What specific method will be used to determine non-replication of viruses?

Additional Attachments (Checklist):

____Copy of principal investigator(s)’ curriculum vitae attached (See the following CV Waiver Statement)

____CV Attached Waiver Principal Investigator: A copy of CV as an attachment can be waived if the principal

investigator has previously submitted a copy of their CV within the last two years and that CV resides on

file with the IRB, or the investigator is a student who is under the guidance of a faculty sponsor.

____Copy of all other investigator(s)’ curriculum vitae attached (See the following CV Waiver Statement)

____CV Attached Waiver All Other Investigators: A copy of CV as an attachment can be waived if all other

additional investigators have previously submitted a copy of their CV within the last two years and that

CV(s) reside on file with the IRB, or the investigators are students who are under the guidance of a

faculty sponsor.

Assurance of Principal Investigator:

I understand experiments involving laboratory animals are not to be conducted unless approved by the Thomas University Institutional Review Board on the issue Recombinant Deoxyribonucleic acid or Recombinant DNA in Research.

I agree to comply with and accept responsibility for the specific and formal training of my staff in all bio-safety Level II Agents that will be utilized within the laboratory. This formalized training will be documented and will include, but not be limited to, personal protective equipment (PPE), spill and release controls, and procedures to be use within the laboratory. All affected support staff must also be notified and formally trained concerning any bio-safety Level II Agents, and protective procedures to be utilized. This training will also be documented.

I agree to comply with the emergency procedures for cleaning spills involving recombinant DNA within the laboratory as described in the National Institutes of Health Laboratory Safety Monograph.

I agree to comply with the National Institutes of Health requirements pertaining to shipment, use and transfer of recombinant DNA materials. I am familiar with and agree to abide by the provisions of the current National Institutes of Health Guidelines, the policies of Thomas University, and the Thomas University Institutional Review Board’s instructions pertaining to this project.

As the Principal Investigator on this project, I certify by my signature below that the information provided in this application is accurate and fully describes any and all procedures regarding Recombinant Deoxyribonucleic acid or Recombinant DNA under, which I will conduct this research.

I, the undersigned, agree to accept responsibility for my co-investigators and other personnel involved on this project, in regards to their compliance with the above stated policies.

I will retain the documentation of the experiment, experimental data, reports and all procedures performed for at least three years after the proposed activity has been completed or discontinued.

The IRB is obligated to continually review this activity. Therefore, I agree to furnish progress reports to the committee when requested.

I, the undersigned, understand and agree that upon approval of this application, should complaint of a violation of any procedures as proposed within this document occur, as deemed through investigation by the Thomas University IRB or bodies employed by Thomas University, this application will be reversed and denied continuation of approval, and the termination of the research under this proposal will be so ordered and enforced to the fullest extent of the law.

Please note: Signature of this application form by the primary investigator provides written assurance that the primary investigator attests that they have read and understand all abovementioned statements concerning Thomas University policy for research or similar activities involving Recombinant Deoxyribonucleic acid or Recombinant DNA in research; federal, state and county regulations and laws where applicable; and certify that they will uphold all regulations and policies as required and prescribed by law, along with the National Institute of Health Recombinant DNA Guidelines, and the Thomas University policy as stated herein.

_________________________________________ _______________

Principal Investigator‘s Signature (SEAL) Date

For faculty supervisor approval:

I believe that the research can be safely completed and conducted within the bounds stated by the National Institutes of Health Recombinant DNA Guidelines. Furthermore, I have read the enclosed proposal, and I am willing to supervise the investigator(s).

_________________________________________ _______________

Faculty Sponsor‘s Signature (SEAL) Date

Response to application for approval of research involving Recombinant Deoxyribonucleic acid or Recombinant DNA

All responses to research will be provided to the principal investigator in writing from the Thomas University Institutional Review Board. According to the complexity of the research, a response from the board (full review of application) may take up to, but not exceed, three weeks. Should further, appropriate review by officials of the institution be deemed necessary, it could delay a response from the Institutional Review Board for an additional two week period beyond the initial three week period. In addition, the request for an expedited review by the principal researcher does not exclude the possibility of a determination of a full committee review. This is held at the discretion of the Institutional Review Board and its Chairperson. When at all possible and should the research request exhibit those criteria that merit an expedited review that option will be exercised by the Institutional Review Board.

For questions, please contact the Thomas University IRB at irb@thomasu.edu.

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Please note: Handwritten applications will not be accepted.

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